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“Is registration of a purely observational study in CTRI mandatory, and what are the regulatory requirements or ethical considerations influencing this decision?”
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The CTRI is a facilitator body that provides a platform for registering clinical studies as mandated by the drug licensing authority, ethics committees and journal editors. Further, the WHO advises ‘When in doubt, register’.
In addition, it may be noted that since 1st April 2018, the CTRI only registers clinical trials prospectively, i.e., before the enrolment of the first patient and hence the decision to register should be made before trial initiation as registration will not be feasible later.